CompletedNCT05526820Updated Sep 2, 2022

A Study of Combined Immunization With Live Attenuated Varicella Vaccine and Inactivated Hepatitis A Vaccine

A Phase 4 interventional study of The live attenuated varicella vaccine and the inactivated hepatitis A vaccine in Varicella, sponsored by Sinovac (Dalian) Vaccine Technology Co., Ltd.. Completed at 1 site in China. Open to participants aged 12 Months to 15 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-09-02.

Sponsored by Sinovac (Dalian) Vaccine Technology Co., Ltd. · Phase 4, Interventional, and Prevention

From the registry’s dates

Registered 1 year 4 months after the study started (first participant enrolled Apr 2021, registered Aug 2022).

Phase: Phase 4
Study type: Interventional
Enrollment: 450
Allocation: Randomized
Ages: 12 Months to 15 Months
Sex: All

Study summary

This study is a randomized and controlled Phase IV clinical trial.The purpose of this study is to evaluate the immunogenicity and safety of combined immunization with live attenuated varicella vaccine and inactivated hepatitis A vaccine in children aged 12-15 months.

Read the detailed description

This study is a randomized and controlled phase IV clinical trial in children aged 1 year old (12-15 months).The purpose of this study is to evaluate the immunogenicity and safety of live attenuated varicella vaccine co-administration with inactivated hepatitis A vaccine .The live attenuated varicella vaccine was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd,the inactivated hepatitis A vaccine was manufactured by Sinovac Biotech Co., Ltd.A total of 450 subjects aged 1 year old (12-15 months) were be enrolled.Subjects were be randomly divided into 2 groups in a ratio of 1:1.Subjects in the combined immunization group received one dose of live attenuated varicella vaccine and the first dose inactivated hepatitis A vaccine on day 0 and the second dose of inactivated hepatitis A vaccine on day 180.Subjects in the Non-combined immunization group received one dose of live attenuated varicella vaccine on day 0,the first dose of inactivated hepatitis A vaccine on day 42 and the second dose of inactivated hepatitis A vaccine on day 222.

Conditions studied

Varicella

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In context

Chickenpox

152 studies on the registry are indexed under Chickenpox; 26 are open to participants now.

This study's enrollment of 450 is close to the median of 478 across 126 interventional studies indexed under Chickenpox.

Browse Chickenpox studies →

Lead sponsor

Sinovac (Dalian) Vaccine Technology Co., Ltd. is the lead sponsor of 20 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 12 Months to 15 Months
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

Healthy child aged 1 year old (12-15 months old);
Proven legal identity;
The subjects'guardians should be capable of understanding the informed consent form, and such form should be signed prior to enrolment.

Exclusion criteria

Exclusion Criteria:

History of vaccination of varicella vaccine or hepatitis A vaccine.
Previous history of varicella infection or hepatitis A infection;
History of asthma, history of allergy to the vaccine or vaccine components, or serious adverse reactions to the vaccine, such as urticaria, dyspnea, and angioedema;
Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc;
Thyroid disease or history of thyroidectomy, asplenia,functional asplenia,asplenia or splenectomy resulting from any condition;
Suffering from serious chronic diseases, serious cardiovascular diseases, liver and kidney diseases, malignant tumors, etc;
Family history of psychosis,severe neurological disease (epilepsy, convulsions or convulsions) or mental illness;
Diagnosed abnormal blood coagulation function (eg, lack of blood coagulation factors, blood coagulopathy, abnormal platelets) or obvious bruising or blood coagulation;
Immunosuppressive therapy, cytotoxic therapy, inhaled corticosteroids(excluding allergic rhinitis corticosteroid spray therapy, acute noncomplicated dermatitis superficial corticosteroid therapy) within 6 months before enrollment;
Receipt of blood products within the past 3 months;
Receipt of other investigational vaccines or drugs within 28 days prior to receiving the investigational vaccine;
Receipt of attenuated live vaccines in the past 28 days;
Receipt of inactivated or subunit vaccines in the past 7 days;
Onset of various acute or chronic diseases within 7 days prior to the study;
Armpit temperature in subjects with fever prior to vaccination with the investigational vaccine. 37.4 ℃;
According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial

Study design

Phase: Phase 4
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 450 participants (actual)

Study arms

Experimental
The combined immunization group
225 participants received one dose of live attenuated varicella vaccine and the first dose inactivated hepatitis A vaccine on day 0 and the second dose of inactivated hepatitis A vaccine on day 180.
Biological: The live attenuated varicella vaccine and the inactivated hepatitis A vaccine
Active comparator
The Non-combined immunization group
225 participants received one dose of live attenuated varicella vaccine on day 0,the first dose of inactivated hepatitis A vaccine on day 42 and the second dose of inactivated hepatitis A vaccine on day 222.
Biological: The live attenuated varicella vaccine and the inactivated hepatitis A vaccine

Interventions

BiologicalThe live attenuated varicella vaccine and the inactivated hepatitis A vaccine
The live attenuated varicella vaccine was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd,the inactivated hepatitis A vaccine was manufactured by Sinovac Biotech Co., Ltd. The live attenuated varicella vaccine:live varicella-zoster virus in 0.5 mL of sucrose, sodium glutamate,sodium chloride,potassium chloride,sodium dihydrogen phosphate, potassium dihydrogen phosphate and injection water per injection. The inactivated hepatitis A vaccine:250 U inactivated virus in 0.5mL of aluminium hydroxide solution per injection. All subjects received hepatitis A vaccine in the upper left arm and varicella vaccine in the upper right arm.

What researchers measure

Primary outcomes

Seroconversion rates of the varicella antibody
Seroconversion rate of varicella antibody 42 days after immunization of live attenuated varicella vaccine.
Time frame: 42 days after immunization of live attenuated varicella vaccine
Seroconversion rates of anti-HAV antibody
Seroconversion rate of anti-HAV antibody 30 days after full immunization with hepatitis A vaccine.
Time frame: 30 days after full immunization with hepatitis A vaccine

Secondary outcomes

Seropositive rates of varicella antibody
Seropositive rates of varicella antibody 42 days after immunization of live attenuated varicella vaccine.
Time frame: 42 days after immunization of live attenuated varicella vaccine
GMT of varicella antibody
GMT of varicella antibody 42 days after immunization of live attenuated varicella vaccine.
Time frame: 42 days after immunization of live attenuated varicella vaccine
GMI of varicella antibody
GMI of varicella antibody 42 days after immunization of live attenuated varicella vaccine.
Time frame: 42 days after immunization of live attenuated varicella vaccine
Seropositive rates of anti-HAV antibody
Seropositive rates of anti-HAV antibody 30 days after full immunization with hepatitis A vaccine.
Time frame: 30 days after full immunization with hepatitis A vaccine
GMC of anti-HAV antibody
GMC of anti-HAV antibody 30 days after full immunization with hepatitis A vaccine.
Time frame: 30 days after full immunization with hepatitis A vaccine
GMI of anti-HAV antibody
GMI of anti-HAV antibody 30 days after full immunization with hepatitis A vaccine.
Time frame: 30 days after full immunization with hepatitis A vaccine
The incidence of adverse events
Incidence of adverse events within 0-42 days (or 0-30 days) after each dose of vaccine.
Time frame: within 0-42 days (or 0-30 days) after each dose of vaccine
The incidence of local and systemic solicitation adverse reactions
The incidence of local and systemic solicitation adverse reactions within 0-14 days (or 0-7 days) after each dose of vaccine.
Time frame: Within 0-14 days (or 0-7 days) after each dose of vaccine
The incidence of serious adverse events (SAE)
The incidence of serious adverse events (SAE) within 42 days (or 30 days) after administration of each dose of vaccine.
Time frame: Within 42 days (or 30 days) after administration of each dose of vaccine

Study locations

1 site

Feicheng Center for Disease Control and Prevention
Tai'an, Shandong, China

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Sep 2, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05526820
Lead sponsor: Sinovac (Dalian) Vaccine Technology Co., Ltd.
Responsible party: Sponsor
First posted: Sep 2, 2022
Start date: Apr 8, 2021
Primary completion: Apr 8, 2021
Completion: Feb 27, 2022
Last update: Sep 2, 2022

Study contacts

Dianmin Kang

principal investigator · Shandong Provincial Center for Disease Prevention and Control

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.

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